It is a standard practice in the industrialized world to disinfect the skin prior to any invasive procedure such as surgery, catheterization, or needle puncture to reduce the risk of infection. Decontamination of the oral cavity and nasal cavity also has been suggested to reduce the incidence of infection in cardiac surgery and/or to reduce spread of Methicillin Resistant Staphylococcus aureus (MRSA) in healthcare facilities. These products are often referred to as skin preps, nasal preps, oral preps, or simply “preps”. It is particularly advantageous to customers to have a single product that can be used on both intact skin and mucosal tissue (e.g., vaginal, oral, nasal, and ocular tissue). Other sensitive tissues that antimicrobial products have been used on include acute and chronic wounds as well as burns. For all of these topical antiseptics it is desirable to achieve a very rapid microbial reduction so that the clinician can get on with the intended procedure.
Recently, there have been several alcohol-based antiseptics on the market for both presurgical and precatherization antisepsis. These products, while good rapid acting antiseptics due to the high alcohol content (e.g., typically at least 60 percent by weight (wt-%)), are only suitable for use on intact skin and are not suitable for use on sensitive tissues such as mucosal tissue, wounds, or burn tissue. High alcohol concentrations can be extremely irritating to these tissues.
More recently there has been a number of papers published showing that patients who carry Staphylococcus aureus (SA) in their nose at the time of surgery are at much greater risk of acquiring a surgical site infection. Thus, what is needed is a presurgical prep that also can be used in the nose and particularly in the anterior nares. The only product routinely used for this purpose in the United States is Bactroban Nasal. This product contains the antibiotic mupirocin. This antibiotic is effective but has been found to generate bacterial resistance quite easily.
It is well known that none of the commercially available skin antiseptics kill all of the bacteria on the skin. For this reason, recent products have incorporated film-forming polymers that resist wash-off during surgery or exposure to fluids. Some of these products also require an organic remover solution or lotion to get the prep off the skin. This is inconvenient for the clinician and requires significant extra time.
Furthermore, many current preps have very low viscosity and thus are messy to apply to body cavities such as the vagina and nose since they spill out. Finally, many of these preps do not kill bacteria very rapidly and/or have an objectionable odor and/or taste. Povidone iodine preps (such as BETADINE 10% povidone-iodine solution from Purdue Frederick, Norwalk, Conn.) are widely recognized for their efficacy on skin and in the vaginal cavity, and for lack of bacterial resistance, but these preps have very low viscosity and do not kill as rapidly as desired. Furthermore, preps such as BETADINE have an unpleasant odor and taste.
Thus, there is still a need for tissue antiseptic compositions.